CONVERGENCE INSUFFICIENCY TREATMENT TRIAL

Southern California College Of Optometry, Fullerton CA

Investigators

Linked publications & trials

Abstract

[unreadable] DESCRIPTION (provided by applicant): This proposal is for the Southern California College of Optometry (SCCO) to serve as one of the 9 clinical centers for the Convergence Insufficiency Treatment Trial (CITT). The CITT is a prospective, randomized, masked, placebo controlled [unreadable] multi-center clinical trial designed to compare the efficacy of two commonly used treatments for patients with convergence insufficiency (CI), a distinct disorder of binocular vision affecting approximately 5% of children and young adults in the United States. The two treatments, pencil push-up therapy and vision therapy/orthoptics, are significantly different in cost and number of office visits required, with pencil push-up treatment being significantly less costly in time and money. In the proposed study, 249 patients with symptomatic convergence insufficiency between the ages of 9 and 30 years will be randomly assigned to: (1) home-based pencil push-up treatment, (2) office-based vision therapy/orthoptics, or 3) a control (placebo office-based vision therapy/orthoptics). Signs and symptoms of convergence insufficiency will be [unreadable] measured by a masked examiner at baseline and every 4 weeks during a 12-week treatment program. The primary outcome measure will be the score derived from the CITT Symptom Survey at the conclusion of treatment; secondary outcomes will be the clinical measures of near point of convergence and positive fusional vergence at near. Successfully treated patients will be followed for an additional 12 months to evaluate the long-term persistence of symptomatic relief and improved clinical findings. This application documents the Southern California College of Optometry's ability to serve as a CITT Clinical Center and meet its objectives which include: (1) recruiting and enrolling at least 30 eligible patients within an 18-month [unreadable] enrollment period, (2) recruiting Hispanic/Latino and Asian patients to ensure ethnic/racial diversity of the study patients, (3) following the CITT recruitment, randomization, examination, treatment, and follow-up protocols for each patient, (4) maintaining patient and examiner masking, and (5) striving for study visits to be completed within the visit windows, with no missed visits and no loss to follow up, and (6) retaining successfully treated patients for an additional 12 month follow-up period. In addition, documentation is contained herein that the SCCO Clinical Center has appropriate personnel, facilities, and equipment to conduct the trial successfully. Complete details of the rationale, design, and methods are contained in the applications submitted by the Study Chair and Data Coordinating Center as well as the Manual of Procedures, which have been submitted separately. [unreadable] [unreadable]